The Ottawa Hospital/The Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Eastern Ontario Regional Laboratory Association, Ottawa, ON, Canada; Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.
Diagn Microbiol Infect Dis. 2019 Nov;95(3):114866. doi: 10.1016/j.diagmicrobio.2019.07.004. Epub 2019 Jul 26.
We compared three commercially available group A Streptococcus (GAS) nucleic acid amplification tests, the Quidel Solana GAS assay, the Luminex Aries Group A Strep assay and the Focus Diagnostics Simplexa Group A Strep Direct assay, with GAS bacterial culture. A true positive result was defined as one positive by culture or positive by ≥2/3 molecular methods. Two hundred eighty-seven throat swabs (207 children, 80 adults) were collected. The sensitivity of culture was 84.8% (95% CI 77.7-90.3%) with a specificity of 100% (95% CI 97.5-100%). The Solana assay sensitivity was 94.2% (95% CI 88.9-97.5%) with a specificity of 98.7% (95% CI 95.2-99.8%). Simplexa assay sensitivity was 99.3% (95% CI 96.0-99.9%) with a specificity of 95.3% (95% CI 90.6-98.1%). Aries assay sensitivity was 96.4% (95% CI 91.8-98.8%) with a specificity of 98.0% (95% CI 94.2-99.6%). In summary, all the molecular methods evaluated showed high sensitivity and specificity and were more sensitive than culture.
我们比较了三种市售的 A 组链球菌（GAS）核酸扩增检测试剂盒，即 Quidel Solana GAS 检测试剂盒、Luminex Aries Group A Strep 检测试剂盒和 Focus Diagnostics Simplexa Group A Strep Direct 检测试剂盒，与 GAS 细菌培养进行比较。真阳性结果定义为培养阳性或≥2/3 分子方法阳性。采集了 287 份咽喉拭子（207 名儿童，80 名成人）。培养的敏感性为 84.8%（95%CI 77.7-90.3%），特异性为 100%（95%CI 97.5-100%）。Solana 检测试剂盒的敏感性为 94.2%（95%CI 88.9-97.5%），特异性为 98.7%（95%CI 95.2-99.8%）。Simplexa 检测试剂盒的敏感性为 99.3%（95%CI 96.0-99.9%），特异性为 95.3%（95%CI 90.6-98.1%）。Aries 检测试剂盒的敏感性为 96.4%（95%CI 91.8-98.8%），特异性为 98.0%（95%CI 94.2-99.6%）。综上所述，所有评估的分子方法均表现出高敏感性和特异性，且比培养更敏感。
